ASCO: Weekly Chemo Better in Ovarian Cancer

by Michael Smith Michael Smith North American Correspondent, MedPage Today
June 05, 2013

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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

In this randomized phase III study, lower-dose weekly carboplatin plus paclitaxel was associated with better quality of life and less toxicity in patients with advanced ovarian cancer compared with standard dosing of these agents every 3 weeks.

CHICAGO -- Shortening the time between chemotherapy sessions improved quality of life in women with advanced ovarian cancer without affecting efficacy, a researcher said here.

In a randomized phase III trial, dubbed MITO-7, weekly chemotherapy with a standard drug combination also had significantly less toxicity than the usual program of sessions every 3 weeks, according to Sandro Pignata, MD, PhD, of the Italian National Cancer Institute in Naples.

And the more frequent sessions led to rates of progression-free survival that were similar to those seen among women getting medication every 3 weeks, Pignata reported at the annual meeting of the American Society of Clinical Oncology.

Standard initial chemotherapy for women with advanced ovarian cancer has been carboplatin (Paraplatin) and paclitaxel (Taxol), given every 3 weeks, Pignata noted. But a 2009 study combining weekly doses of paclitaxel with carboplatin given every 3 weeks showed a significant improvement in progression-free survival and overall survival.

Pignata and colleagues tested a weekly regimen of both drugs, at lower doses, against the standard regimen in 822 patients, of whom 808 were available for an intent-to-treat analysis.

The primary endpoints of the study were progression-free survival and quality of life, as measured by the Functional Assessment of Cancer Therapy (FACT) questionnaires, administered weekly for 9 weeks.

The researchers also examined overall survival and toxicity as secondary endpoints.

With a median follow-up of 20 months, Pignata reported, 410 women had progressed, and the median time to progression was 18.8 months in the weekly arm and 16.5 months among those who got therapy every 3 weeks.

However, the difference did not reach statistical significance, Pignata reported.

The data for overall survival are not mature, he reported, but so far show no significant difference between the arms.

On the other hand, both quality of life and toxicity were significantly better for women getting medication once a week, he said.

For women in the weekly arm, quality of life remained constant from baseline through the first 9 weeks of therapy. Women on the 3-week schedule, however, had sharp drops in quality of life in the days after their medication.

The differences between the arms at those times were significant, at values ranging from P<0.05 to P<0.001, Pignata reported.

In addition, women in the weekly arm had significantly lower rates of some serious adverse events, including neutropenia, febrile neutropenia, and platelet loss. They were also less likely to lose their hair or to suffer neuropathy and renal toxicity, he reported.

The findings "further support the use of a weekly schedule as first-line treatment for advanced ovarian cancer," Pignata concluded.

The study underscores the need to pay attention to the scheduling of therapy, commented Larry Norton, MD, of Memorial Sloan-Kettering Cancer Center in New York City. "It's not just picking two regimens out of the air," he told MedPage Today. "Scheduling is important, and it needs to be based on science."

Physicians and researchers are "not spending enough time on the science of scheduling," he added.

Norton said the results of the study would clearly have been better if there had been more efficacy with the shorter regimen, but equivalent efficacy and lower toxicity is also a win for patients.

UPDATE: This article, originally published on June 4 at 3:34 p.m., was updated with new material on June 5 at 1:13 p.m.

The study was supported by the Italian National Cancer Institute.

Pignata and other authors said they had no relevant financial disclosures.

Reviewed by Zalman S. Agus, MD Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania

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